Comments for Deciphering Hemispherx (AMEX:HEB) at http://www.biomedreports.com , comment 1 to 7 out of 7 comments http://www.biomedreports.com Wed, 08 Feb 2012 02:51:45 +0100 FeedCreator 1.7.3 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-299 There is no legal/any obligation for a company to release a non-approval or approvable letter - straight from the FDA: Doug, Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research. Once a drug is approved the company generally makes the results known immediately. However, there are not requirements for a company to make public a non-approval or approvable letter for a drug. Best Regards, BD Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. -----Original Message----- From: druginfo@fda.hhs.gov [mailto:druginfo@fda.hhs.gov] Sent: Friday, June 12, 2009 2:17 PM To: CDER DRUG INFO Subject: DrugInfo Comment Form FDA/CDER Site Name: Doug E-Mail: rwefree1@yahoo.com Comments: Hello, If a company receives an approval,non-approval, or approvable letter for a drug, is there a legal or required amount of time that the company has to make the result public within? Thanks, Doug URL: - Doug Fri, 12 Jun 2009 14:21:24 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-282 It surprises me that no one has looked further into the reasons for the "staff scheduling changes"..The first article that came to my attention was the appointment of the new FDA commissioner, Dr Margaret Hamburg. Her appointment was not confirmed by the senate until May 18th, one week before the original decision date of May 25th..I'm sure there were changes that were necessary for her to take office, none of which are HEB's fault. This is not the only drug that was delayed at that time..Johnson & Johnson also had a drug for psoriasis that was delayed on May 27th for the second time! Do you see anyone blaming J&J because of their delay? - Bobbie Gibson Fri, 12 Jun 2009 09:45:33 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-205 HEB calls FDA HEB: Did you approve it yet? FDA: Approve what? HEB: Ummm... Ampligen FDA: let me see here, what is the drug for? HEB: CFS, AIDS and SARS FDA: wait how many drugs are you calling about HEB: just Ampligen FDA: HAHA, ok there buddy,ONE SECOND PLEASE (background) Harry: "HEY BILLY DID YALL APPROVE THAT AMPLIGEN SH!T?" Billy: "NO HARRY, WE NEED MORE RATS" FDA: No sir, we don't have enough rats HEB: WHAT?!?! FDA: I'm sorry I mean we don't have a decision yet, give us 3 month 3 month later HEB: Did you approve it yet? FDA: Approve what? HEB: Ummm... Ampligen FDA: Hold on please. (background) Billy:" AY harry, What happened to the rats" Harry:"Which ones Billy?" Billy: "the ones all the way in the back man" HARRY: " They been humpin each other for the past 3 month so I told my wife to buy 5 million shares" Billy: "Sh!t harry, that isn't the new Viagra, the Viagra rats are in the front" HARRY: "Sh!T Billy, Tell em we need 2 more weeks" FDA: Hello HEB: Yes sir... FDA: The rats are humping each other HEB: WHAT?!? FDA: I mean we need two more weeks. HEB: What the hell are you talking about FDA: (HANGS UP) 2 weeks later heb calls again FDA: HEllo HEB: Hi, I'm calling about.. FDA: Hold on, yep approved HEB: I didn't even finish the sentence. FDA: yea everything was approved today. HEB: I'm calling about Ampli.. FDA: yea yea approved.. Background Billy: what the hell is that noise in the back Harry: Go check it out man I'm on the phone Billy: who left the back cage open the damn it, the bats are everywhere Harry: What are you talking about Billy, we don't have bats here. HEB hangs up, Dr. Carter: Hey Kelly, We are changing the campaign adds, Ampligon gives you wings! oh and publicize that 150 million dollar offering now! - from yahoo finance Thu, 11 Jun 2009 00:03:09 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-203 What timeline are we looking at between when the company receives the FDA approval/non-approval letter and when they make it public? Is there a required amount of time, or can the company sit on the non-approval until they decide the time is right to make it public? - Doug Wed, 10 Jun 2009 21:18:48 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-200 I was wondering if someone at biomedreports could try to contact Hemispherx to see what is happening and why a decision is yet to be made/announced? - HEB investor Wed, 10 Jun 2009 01:10:44 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-199 I feel sorry for CFS patients... there is clearly something wrong here, this is not the drug they have been waiting for - bricconcello Wed, 10 Jun 2009 01:01:26 +0100 http://www.biomedreports.com/200906101220/deciphering-hemispherx.html#comment-198 Today marks the new beginning for HEB. Dr. Carter should be up for the Nobel Prize. He has tried so hard for so many years to introduce a drug that has far reaching consequences. Least of all, the legitimacy that he has brought to CFS sufferers is outstanding. We at the Yahoo Message Board (HEB) want to thank you for your unbiased efforts in telling the truth, seeking to go further than Political Science brings, into a masterful truly engaging approach of balance, understanding, and yes … thought provoking analysis of the Pharma Industry - the otter way Tue, 09 Jun 2009 23:15:57 +0100